Model Number 71992-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the libre sensor and libre sensor kit were reviewed, and the dhrs showed the libre sensor and libre sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A heavy bleeding issue was reported the adc device.The customer was treated with a bandage and unspecified antibiotic cream by spouse.No further information was provided.There was no report of death or permanent injury associated with this event.
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Event Description
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A heavy bleeding issue was reported the adc device.The customer was treated with a bandage and unspecified antibiotic cream by spouse.No further information was provided.There was no report of death or permanent injury associated with this event.
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Manufacturer Narrative
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Applicator (b)(6) has been returned and investigated.Visually inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly.The applicator was opened to inspect the sharp and no issues were observed.Sensor (b)(6) has been returned and investigated.Visual inspection was performed on the sensor and no issues were observed.The sensor plug was fully seated.Inspected the plug assembly, no issues were observed.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
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Search Alerts/Recalls
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